Testicular HydroceleNCT02082613
Lord´s Procedure Versus Sclerotherapy for Testicular Hydrocele; a Randomized Controlled Study
A study testing Lord´s procedure and Sclerotherapy in people with Testicular Hydrocele, run by Umeå University at 7 sites in 2 countries.
Trial summary
This study will compare a minimal invasive operation in local anesthesia with sclerotherapy for symptomatic testicular hydrocele within 6 months after randomization. Thirty days complication rates will be assessed. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Testicular Hydrocele
- What is being tested?
- Lord´s procedure and Sclerotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Feb 2015to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic testicular hydrocele, with more than 2 points on a validated inguinal botherscore (Inguinal Pain Questionnaire, IPQ)
- More than 40ml of hydrocele fluid
- Age>40 years
- Completed reproduction
- Oral and written consent to participate in the study
- American Association of Anesthesiology (ASA) grade≤ 3
Who cannot join
- Other ipsilateral scrotal disease (tumour, ongoing inflammatory disease of the scrotum,)
- Ongoing urinary infection
- Ipsilateral inguinal hernia
- Ascites
- Paternity wish
- Not possible to drain the hydrocele fully
- Opaque fluid drained on emptying the hydrocele
- Bilateral hydrocele where both sides has symptom score more than 2p on IPQ.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Sweden6 sites, 6 recruiting
- Recruiting
Falu lasarett
Falun, Dalarna County
Carl Gustav Arvidsson, M.D
Nils Edström, M.D
- Recruiting
Helsingborgs sjukhus
Helsingborg, Skåne County
Andreas Forsvall, M.D
- Recruiting
Sunderby Hospital
Luleå, 97180
Ioannis Beis, MD, ioannis.beis@nll.se
- Recruiting
Östersunds hospital
Östersund, Jämtland County, 83183
Karl-Johan Lundström, M.D
- Recruiting
Sundsvalls hospital
Sundsvall, Västernorrland County
Johan Styrke, MD, 0046-70-2992048, johan.styrke@umu.se
- Recruiting
Umea University Hospital
Umeå, 90185
Jon Fridriksson, MD, jon.fridriksson@umu.se
Norway1 site, 1 recruiting
- Recruiting
Drammen Hospital
Drammen, 3004
Sven Petter Haugvik, M.D
About this study
Official title: Lord´s Procedure Versus Sclerotherapy for Testicular Hydrocele; a Randomized Controlled Study.
This study will compare a minimal invasive operation in local anesthesia with sclerotherapy for symptomatic testicular hydrocele within 6 months after randomization. Thirty days complication rates will be assessed. The hypothesis is that surgery will lead to faster cure while sclerotherapy would be cheaper and have less complications.
Read the detailed description
Testicular hydrocele is a common disorder even though it´s exact prevalence is unknown. In areas with filariasis it´s endemic.
Hydrocele is a benign condition where fluid accumulates in between two layers of tunica vaginalis (embryologically, the peritoneum), surrounding the testicle. The cause is unknown but inflammatory conditions is believed to induce these changes. The pathogenesis of hydrocele is believed to be a nonbalanced secretion and resorption of fluid.
Diagnosis of hydrocele is easy since the patient presents with an enlarged scrotum and clinical investigation including palpation and transillumination of the scrotum confirms the diagnosis. A scrotal ultrasound might be indicated to rule out a malignancy or if the diagnosis is unclear.
Treatment for hydrocele is only indicated when the patient has symptoms since all treatment modalities carries risk of complications, such as hematoma, infection, pain and even infertility concerns has been raised.
Operative management is considered the golden standard of treatment when considering recurrence but less invasive procedures such as sclerotherapy is frequently used, mainly due to cost and complications issues.
Lord´s procedure has in several series shown low frequency of complications and excellent recurrence rates. However, Lord´s procedure and sclerotherapy has not been tested head to head and the optimal treatment for hydrocele is yet to be determined.
This study aims to compare these techniques and evaluate the results within 1 year after randomization on cure, complication rates and various secondary descriptive outcomes.
The investigators aim to adhere to CONSORT.
- Conditions
- Testicular Hydrocele
- Being tested
- Lord´s procedure, Sclerotherapy
- Keywords
- Testicular hydrocele, Hydrocele, Sclerotherapy, Surgery, Complications
- Medical subject headings
- Testicular Hydrocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lord´s procedureProcedure or surgery
SclerotherapyProcedure or surgery
Also called Polidocanol 30mg/ml, 4ml, Aetoxysclerol™ 30mg/ml, 4ml, Lauromakrogol 400 30mg/ml, 4ml
| Study group | Role | What they receive |
|---|---|---|
| Lord´s procedure | Experimental | Lord´s procedure for testicular hydrocele, under local anesthesia in a conventional operation room, under sterile conditions Receives: Procedure: Lord´s procedure |
| Sclerotherapy | Active comparator | Sclerotherapy with 4 ml of polidocanol 30mg/ml after complete emptying of the hydrocele. With or without local anesthesia, not performed in an operation room. Receives: Procedure: Sclerotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure from symptomatic hydrocele within 6 months of randomization
Measured: Every 3 months until 6months from randomization
Secondary outcomes (1)
Postoperative complications
Measured: Within 30 days from treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2014 (estimated)
- Study startFeb 2015
- Primary completionDec 2016 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Testicular HydroceleStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karl-Johan Lundström, Umeå University
- Investigators
- Pär Nordin, Ph.D, MD, Study director, Umeå UniversityKarl-Johan Lundström, M.D, Principal investigator, Östersunds Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02082613
- Sponsor's protocol ID
- JLL-378961
- Status last verified
- Apr 2016
- First submitted
- 6 Mar 2014
- Last updated
- 7 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lord´s Procedure Versus Sclerotherapy for Testicular Hydrocele; a Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT02082613
- Acronym / sponsor ID
- JLL-378961
- Conditions
- Testicular Hydrocele
- Keywords
- Testicular hydrocele, Hydrocele, Sclerotherapy, Surgery, Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 10 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare a minimal invasive operation in local anesthesia with sclerotherapy for symptomatic testicular hydrocele within 6 months after randomization. Thirty days complication rates will be assessed. The hypothesis is that surgery will lead to faster cure while sclerotherapy would be cheaper and have less complications.
Detailed description
Testicular hydrocele is a common disorder even though it´s exact prevalence is unknown. In areas with filariasis it´s endemic.
Hydrocele is a benign condition where fluid accumulates in between two layers of tunica vaginalis (embryologically, the peritoneum), surrounding the testicle. The cause is unknown but inflammatory conditions is believed to induce these changes. The pathogenesis of hydrocele is believed to be a nonbalanced secretion and resorption of fluid.
Diagnosis of hydrocele is easy since the patient presents with an enlarged scrotum and clinical investigation including palpation and transillumination of the scrotum confirms the diagnosis. A scrotal ultrasound might be indicated to rule out a malignancy or if the diagnosis is unclear.
Treatment for hydrocele is only indicated when the patient has symptoms since all treatment modalities carries risk of complications, such as hematoma, infection, pain and even infertility concerns has been raised.
Operative management is considered the golden standard of treatment when considering recurrence but less invasive procedures such as sclerotherapy is frequently used, mainly due to cost and complications issues.
Lord´s procedure has in several series shown low frequency of complications and excellent recurrence rates. However, Lord´s procedure and sclerotherapy has not been tested head to head and the optimal treatment for hydrocele is yet to be determined.
This study aims to compare these techniques and evaluate the results within 1 year after randomization on cure, complication rates and various secondary descriptive outcomes.
The investigators aim to adhere to CONSORT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lord´s procedure | Experimental | Procedure: Lord´s procedureLord´s procedure for testicular hydrocele, under local anesthesia in a conventional operation room, under sterile conditions |
| Sclerotherapy | Active comparator | Procedure: SclerotherapySclerotherapy with 4 ml of polidocanol 30mg/ml after complete emptying of the hydrocele. With or without local anesthesia, not performed in an operation room. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Symptomatic testicular hydrocele, with more than 2 points on a validated inguinal botherscore (Inguinal Pain Questionnaire, IPQ)
- More than 40ml of hydrocele fluid
- Age>40 years
- Completed reproduction
- Oral and written consent to participate in the study
Key exclusion criteria (8 listed)
- Other ipsilateral scrotal disease (tumour, ongoing inflammatory disease of the scrotum,)
- Ongoing urinary infection
- Ipsilateral inguinal hernia
- Ascites
- Paternity wish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lord´s procedure | Procedure or surgery | Lord´s procedure |
| SclerotherapyAlso: Polidocanol 30mg/ml, 4ml, Aetoxysclerol™ 30mg/ml, 4ml, Lauromakrogol 400 30mg/ml, 4ml | Procedure or surgery | Sclerotherapy |
Primary outcome
Cure from symptomatic hydrocele within 6 months of randomization
Time frame: Every 3 months until 6months from randomization
1 secondary outcome
Postoperative complications
Time frame: Within 30 days from treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pär Nordin, Ph.D, MD study director
Umeå University
Karl-Johan Lundström, M.D principal investigator
Östersunds Hospital
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lord´s procedure and Sclerotherapy in people with Testicular Hydrocele, run by Umeå University at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Sweden, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karl-Johan Lundström, M.D (004663153000, karl-johan.lundstrom@jll.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure from symptomatic hydrocele within 6 months of randomization (time frame: Every 3 months until 6months from randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2016.